The present invention relates to a container cap for a liquid-filled or empty container such as a vial or a bag and a liquid communication adapter attachable to a container mouth. The present invention also relates to a container cap and a liquid communication adapter attachable to a container mouth that are useful for mixing medicine used as a mixture with other medicine or medicine by being dissolved in a solvent immediately before an administration, for example, a powder or lyophilized antineoplastic agent, antibiotic or blood product, with the other liquid medicine or the solvent.
In general, when stored as a liquid medicine in a container such as a vial or a bag, an antineoplastic agent, antibiotics, a blood product or a lyophilized preparation have a problem of having reduced stability and efficacy. Therefore, in medical institutions such as hospitals, such a medicine conventionally has been dissolved immediately before being used for an instillation treatment. Such an operation conventionally has included filling a solvent etc. in a syringe to which a sharp needle is attached and piercing a rubber-like stopper of the vial etc. with the needle. However, in the case of using the sharp needle, even with great care being taken, users such as nurses sometimes prick themselves accidentally.
Furthermore, when a different type of liquid medicine is mixed/introduced through a three-way valve attached to some point partway along a liquid feed line of an infusion or blood transfusion set while giving an infusion or blood transfusion to a patient, the operation has involved drawing up the liquid medicine from a container such as a vial by a syringe with a needle attached thereto, removing the needle from the syringe and then fit-connecting a luer of the syringe to the three-way valve, which has been complicated. In addition, when the needle is attached to/removed from the syringe, there have been risks of accidental pricks and liquid medicine contamination.
Moreover, when the liquid medicine in the container such as the vial is drawn up with the syringe little by little and over and over again, a part of the rubber-like stopper that is degraded due to the many repeated piercings is removed by an opening at the tip of the needle, thus causing coring. The resulting fragment falls into the contents of the vial so as to contaminate the liquid medicine.
In order to solve these problems, inventive efforts have been made such as connecting a syringe to which a blunt cannula is attached and a vial using a communication tool such as an adapter or a connection tube, thus infusing or drawing up liquid medicine.
For example, JP 3(1991)-504571 A mainly discloses an injection site that supports within a housing a sealing member through which a blunt cannula can be inserted repeatedly.
JP 5(1993)-168679 A mainly discloses an adapter including a collar member engaging a neck of a vial, a cannula piercing a stopper of a container and a female receptor for receiving a male luer of a syringe provided at a distal end of the cannula. The male luer of the syringe is sealed and temporarily held in the female receptor by a rib formed in a circumferential direction in the female receptor and further an annular protrusion (an annular rib) formed at a site contacting a tip of the male luer.
Alternatively, JP 7(1995)-75663 A also discloses a method of using a rubber-like stopper provided with a piercing hole penetrating therethrough in a container mouth. This piercing hole penetrates the rubber-like stopper ark, using a metal needle having a diameter of about 1 mm and is small enough not to be observed easily with the naked eye from the surface. This piercing hole is closed because of the self-sealing characteristics of the rubber when a cannula is not piercing, while the surface of the piercing hole is in close contact with a circumference of the cannula because of the self-sealing characteristics of the rubber when the cannula is piercing.
However, the method disclosed in JP 3-504571 A requires a cannula exclusively for the insertion through the sealing member. Also, there is no description that a commonly used syringe can be used. Thus, a problem may arise in that a mixing/introducing operation is not possible with respect to an infusion or blood transfusion set having a three-way valve as a mixing/introducing port.
Also, in JP 5-168679 A, although a commonly used syringe can be used, there is a problem in air-tightness between the male luer of the syringe and the female receptor. In particular, when dissolving powder preparations, there are some cases where liquid medicine is filled in or taken out of the pierced syringe or the container such as the vial is inclined, raising a chance of liquid leakage during the operation. In addition, because of its concave shape, the female receptor is difficult to sterilize, raising the possibility of developing an insanitary condition.
Furthermore, JP 7-75663 A does not seem to be suitable for repeated uses. This is because the many repeated piercings of a cannula having a diameter of about 3 to 4 mm through the piercing hole having a diameter of about 1 mm generates a crack in some portion of the circumference of the piercing hole. If this piercing is repeated further, a gap is generated between the cannula and the rubber-like stopper, then the liquid may leak from this gap. Moreover, although this method is suitable for inserting a spike having a relatively sharp tip, it is not suitable for an insertion member such as a syringe luer having a flat end face at its tip. The reason is that a piercing resistance during the insertion is large and that the above-described crack of the rubber-like stopper is likely to occur. In addition, although the self-sealing characteristics of the rubber can bring the stopper described above into close contact with the circumference of the cannula, it is impossible to hold the inserted cannula stably so as not to move in a loose manner.
In order to solve the problems described above, it is an object of the present invention to provide a container cap or a liquid communication adapter, in which many repeated piercings do not cause degradation in a rubber-like stopper of a vial, that can be engaged with a luer of a commonly used syringe, reliably can keep air-tightness with the syringe luer when the luer is connected, reliably can prevent liquid leakage when the luer is not connected, and further can allow an easy and reliable sterilization of a piercing site.
In order to solve the problems described above, a container cap according to the present invention includes at least one disk-like valve provided with an insertion hole in a central portion thereof, and a cover for restraining the valve by covering at least an upper periphery of the valve. A lower periphery on a back surface of the valve is supported by a seating portion of a container mouth or a seating portion of a joint that is supported by the container mouth, and the container cap has an anchor means for anchoring an insertion member to the cap by using a peripheral edge forming a fitting hole in the cover, when inserting the insertion member into the insertion hole.
With this configuration, it is possible to carry out the above-described operations of preparing medicine without using a sharp needle at all. Also, even many repeated piercings do not cause degradation in a rubber-like stopper of a vial, thus reducing a possibility of liquid medicine contamination because of coring.
Furthermore, when drawing liquid medicine into a commonly used syringe and then mixing/introducing this liquid medicine into a blood circuit or an infusion or blood transfusion set to which a three-way valve or a mixing/introducing port capable of receiving an insertion member such as the commonly used syringe luer is attached, it is possible to perform a series of operations without using a sharp needle at all. Accordingly, the needle used for drawing up the liquid medicine etc. becomes unnecessary, thus reducing costs. Also, because the needle does not need to be attached/removed before the mixing/introducing, the operation is simplified. Furthermore, it is possible to reduce the possibility of accidental pricks and liquid medicine contamination, which have accompanied when the needle is attached to/removed from the syringe.
Moreover, since the structure is relatively simple, there is an advantage of reduced percent defective products and less failure in products.
Also, in the container cap according to the present invention, either the combination of the cover and the seating of the container mouth or that of the cover and the seating provided in the joint may restrain the disk-like valve. However, when it is difficult to form the container mouth functioning to restrain the valve in cooperation with the cover and the container mouth is formed of a material incapable of achieving sufficient dimensional accuracy to keep a sufficient liquid tightness, it is desirable to provide the joint made of an easily-moldable material, so as to restrain the valve by the seating of the joint and the cover.
In addition, in the container cap according to the present invention, it is preferable that the joint has a supported portion that is supported by the container mouth. This is because, although the joint may be supported by a supporting portion provided in the container main body, when the container is a conventional container, for example, a vial, the use of the joint having the supported portion that can be supported by the conventional container makes it possible to use this container cap for the conventional container.
Also, it is preferable that the container cap according to the present invention has an anchor means to the container mouth on an inner surface at a lower end of a side portion of the cover. This makes it possible to fasten the container cap main body and the container mouth reliably, and to reduce the possibility that an adhesive or the like is eluted into liquid medicine to be infused or collected because a solvent such as the adhesive is not needed for the fastening.
Furthermore, the container cap according to the present invention may have at least one notch in the side portion of the cover. This allows an easy attachment of the cover.
Moreover, in the container cap according to the present invention, the cover may have at least two leg portions, whose lower ends are provided with an anchor means to the container mouth. This allows an easy attachment of the cover.
Also, it is preferable that the container cap according to the present invention further includes an annular rib that is formed annularly along an upper peripheral edge of the joint forming a hole provided in an upper portion of the joint. Even when the insertion of the insertion member into the container cap has deformed the valve, it is possible to prevent liquid leakage between the valve and the seating and to improve valve reclosing characteristics and valve recovering performance from a downward deflection at the time of removing the insertion member.
Also, it is preferable that the container cap according to the present invention further includes an O-ring between the joint and the container mouth. This can keep air-tightness in a more preferred manner.
In the container cap according to the present invention, it is preferable that the anchor means is a circular fitting hole formed at a center of the cover and anchors the insertion member by the peripheral edge forming the fitting hole in the cover. This makes it possible to anchor the insertion member easily without using any anchor means having a special mechanism. Also, since the insertion member can be anchored while penetrating the disk valve, it becomes possible not only to infuse liquid but also to collect the liquid.
Furthermore, in the container cap according to the present invention, it is preferable that the fitting hole has a diameter of 3.9 to 4.4 mm, and the cover forming the fitting hole has a thickness of 0.3 to 1.0 mm in a portion contacting the insertion member. The values outside this range make it difficult to anchor the insertion member and pose problems in wiping off the liquid and sterilization because of an increased space between the fitting hole and the valve.
Moreover, in the container cap according to the present invention, it is preferable that an annular groove is formed on a thin portion of the disk-like valve, for example, a front surface of the disk-like valve. Since the valve can be extended more easily based on the annular groove by the insertion of the insertion member such as the luer, along with the annular rib described above, a portion compressing the disk-like valve and a portion to be extended by the insertion of the insertion member such as the luer can be considered divided, thereby achieving both the air-tightness and the operability/reclosing characteristics at the same time.
In addition, in the container cap according to the present invention, it is preferable that an annular hook engaging with the annular groove formed on the front surface of the disk-like valve is formed in a restraining portion of the cover. This is because, when the annular groove is formed on the surface, it is necessary to prevent the liquid medicine from accumulating in this groove.
Also, in the container cap according to the present invention, it is preferable that the insertion hole is a linear slit having a length L0 of 2.5 to 4.5 mm. The slit shorter than 2.5 mm makes it difficult to insert the insertion member, while that longer than 4.5 mm may cause leakage of the liquid medicine from both ends of the slit during the insertion of the insertion member. It is further preferable that the length L0 of the slit is 3.0 to 4.0 mm. The values within this range allow a smooth insertion of the insertion member and eliminate the possibility of the leakage of the liquid medicine from both ends of the slit during the insertion or removal of the insertion member.
The outer circumferential shape of the disk valve can be circular, elliptical or polygonal.
Also, in the container cap according to the present invention, it is preferable that a ratio of an outer diameter D2 of the valve to the length L0 of the slit is 1.1xe2x89xa6D2/L0. The value smaller than 1.1 may present risks of deformation and damage/breakage of the valve by the insertion of the insertion member.
Furthermore, in the container cap according to the present invention, it is preferable that the valve has a thickness of 1.0 to 2.0 mm. This is because, in order to insert the insertion member more easily, the disk valve preferably should be thin to the extent that the liquid leakage is not caused. In particular, it is more preferable that the valve has a thickness of 1.0 to 2.0 mm in a portion of the insertion hole.
Moreover, in the container cap according to the present invention, it is preferable that the valve is formed of an elastic material having a JIS-A hardness of 20 to 55.
In the container cap according to the present invention, it is preferable that a material for the valve is selected from the group consisting of a silicone rubber, a natural rubber, a synthetic rubber and a thermoplastic elastomer. By selecting such materials, it becomes easier to retain properties such as air-tightness, insertion characteristics and reclosing characteristics.
Also, in the container cap according to the present invention, when the material for the valve is selected from the group consisting of the silicone rubber, the natural rubber and the synthetic rubber, a film preferably is arranged somewhere from a position that may rupture by the insertion of the insertion member to the back surface of the valve. This makes it possible to prevent additives from eluting because of the contact of the back surface of the valve with the liquid medicine in the container main body when the liquid medicine is stored. The material for this film preferably is polyethylene or polypropylene that has heat resistance and chemical resistance.
In addition, this film preferably has a mechanical property in which the insertion of the insertion member easily can rupture the film but does not cause a ruptured fragment to fall in. This can prevent the ruptured fragment from falling so as to contaminate the liquid medicine.
Furthermore, as other means for preventing elution of the additives caused by the contact of the back surface of the valve with the liquid medicine in the container main body, the back surface of the valve may be coated with a resin such as polyethylene or polypropylene.
Also, in order to prevent the surface of the container cap from being contaminated until immediately before drawing or infusing the liquid, the container cap according to the present invention preferably is provided with a protective member coating at least a portion exposed to the outside of the valve. Such a protective member may be, for example, a cap to be attached to the container cap, an aluminum foil coated with a plastic, namely, a tamper seal fused or affixed onto an upper surface of the container cap or a pull-ring that can be cut and separated from a cover provided on an upper surface of the cover of the container cap.
Moreover, in the container cap according to the present invention, it is preferable that at least two protrusions are provided in a periphery of a side surface of the cover, and the container cap has an anchor means for anchoring the insertion member by a cylindrical lock adapter whose bottom is provided with notches engaging with the protrusions, that has the insertion member inserted and restrained therethrough and inserts the insertion member into the insertion hole and rotates the bottom, thereby engaging the notches provided at the bottom with the protrusions of the cover. This makes it possible to use even an insertion member that cannot be inserted directly into the container cap, for example, a luer of a luer lock syringe.
Next, in order to achieve the above-mentioned object, a liquid communication adapter according to the present invention at least includes a cannula for piercing a stopper of a container, and at least one disk-like valve placed at a proximal end of the cannula and provided with an insertion hole in a central portion thereof. An insertion member extending inward through the valve and the container are in a liquid communication with each other. The liquid communication adapter includes a seating for supporting a lower periphery on a back surface of the valve, and a cover for restraining the valve covering at least an upper periphery of the valve, and has an anchor means for anchoring the insertion member to the adapter by using a peripheral edge forming a fitting hole in the cover, when inserting the insertion member into the insertion hole.
With this configuration, when using a commonly used syringe, and drawing liquid medicine into the syringe and then mixing/introducing this liquid medicine into a blood circuit or an infusion or blood transfusion set to which a three-way valve or a mixing/introducing port capable of receiving an insertion member such as the commonly used syringe luer is attached, it becomes possible to perform a series of operations without using a sharp needle at all. Accordingly, the needle used for drawing up the liquid medicine etc. becomes unnecessary, thus reducing costs. Also, because the needle does not need to be removed before the mixing/introducing, the operation is simplified. Furthermore, it is possible to reduce the possibility of accidental pricks and liquid medicine contamination, which have accompanied the needle being attached to/removed from the syringe. In addition, it is possible to carry out the above-described operations of preparing medicine without using a sharp needle at all. Also, even many repeated piercings do not cause degradation in a rubber-like stopper of a vial, thus reducing a possibility of liquid medicine contamination because of coring.
Moreover, since the structure is relatively simple, there also is an advantage of reduced percent defective products and less failure in products.
In addition, in the liquid communication adapter according to the present invention, it is preferable that at least two protrusions are formed on a side surface of the proximal end of the cannula, and at least two notches engaging with the protrusions are formed on the cover. This makes it possible to fasten the liquid communication adapter main body and the cover reliably, and to reduce the possibility that an adhesive or the like is eluted into the liquid to be infused or collected because a solvent such as the adhesive is not used for the fastening.
Also, it is preferable that the liquid communication adapter according to the present invention further includes an annular rib that is formed annularly along an upper peripheral edge of the seating forming a hole provided in the seating. Even when the insertion of the insertion member into the liquid communication adapter has deformed the valve, it is possible to prevent liquid leakage between the valve and the seating and to improve valve reclosing characteristics and valve recovering performance from a downward deflection at the time of removing the insertion member.
Furthermore, in the liquid communication adapter according to the present invention, it is preferable that the anchor means is a circular fitting hole formed at a center of the cover and anchors the insertion member by the peripheral edge forming the fitting hole in the cover. This makes it possible to anchor the insertion member easily without using any anchor means having a special mechanism. When medicine is prepared by filling a solvent into a vacuum vial containing a powder preparation, for example, a syringe can be left standing by using this anchor means because it is supported upright and does not lean. While left standing, the solvent in the syringe is drawn into the vial by a negative pressure therein, and therefore, it is possible to prepare a plurality of medicines in the meantime. Also, since the insertion member can be anchored while penetrating the disk valve, it becomes possible not only to infuse liquid but also to collect the liquid.
Moreover, in the liquid communication adapter according to the present invention, it is preferable that a filter is provided in a lower portion of the seating. This can prevent impurities such as a dust adhering to the surface from entering into the liquid medicine.
Furthermore, in the liquid communication adapter according to the present invention, it is preferable that the fitting hole has a diameter of 3.9 to 4.4 mm, and the cover forming the fitting hole has a thickness of 0.3 to 1.0 mm in a portion contacting the insertion member. The values outside this range make it difficult to anchor the insertion member and pose problems in wiping off the liquid and sterilization because of an increased space between the fitting hole and the valve.
Moreover, in the liquid communication adapter according to the present invention, it is preferable that an annular groove is formed on a thin portion of the disk-like valve, for example, a front surface of the disk-like valve. Since the valve can be extended more easily based on the annular groove by the insertion of the insertion member such as the luer, along with the annular rib described above, a portion compressing the disk-like valve and a portion to be extended by the insertion of the insertion member such as the luer can be considered divided, thereby achieving both the air-tightness and the operability/reclosing characteristics at the same time.
In addition, in the liquid communication adapter according to the present invention, it is preferable that an annular hook engaging with the annular groove formed on the front surface of the valve is formed in a restraining portion of the cover. This is because, when the annular groove is formed on the surface, it is necessary to prevent the liquid medicine from accumulating in this groove.
Also, in the liquid communication adapter according to the present invention, it is preferable that the insertion hole is a linear slit having a length L0 of 2.5 to 4.5 mm. The slit shorter than 2.5 mm makes it difficult to insert the insertion member, while that longer than 4.5 mm may cause leakage of the liquid medicine from both ends of the slit during the insertion of the insertion member. It is further preferable that the length L0 of the slit is 3.0 to 4.0 mm. The values within this range allow a smooth insertion of the insertion member and eliminate the possibility of the leakage of the liquid medicine from both ends of the slit during the insertion/removal of the insertion member.
The outer circumferential shape of the disk valve can be circular, elliptical or polygonal.
Also, in the liquid communication adapter according to the present invention, it is preferable that a ratio of an outer diameter D2 of the valve to the length L0 of the slit is 1.1xe2x89xa6D2/L0. The value smaller than 1.1 may present risks of deformation, damage/breakage of the valve by the insertion of the insertion member.
Furthermore, in the liquid communication adapter according to the present invention, it is preferable that the valve has a thickness of 1.0 to 2.0 mm. This is because, in order to insert the insertion member easily, the disk valve preferably should be thin to the extent that the liquid leakage is not caused. In particular, it is more preferable that the valve has a thickness of 1.0 to 2.0 mm in a portion of the insertion hole. Moreover, it is further desirable that the valve is formed of an elastic material having a JIS-A hardness of 20 to 55.
Also, in the liquid communication adapter according to the present invention, it is preferable that when the insertion member is fitted through the valve, a maximum inserted depth Dmax, an inserted depth D, a valve thickness L1 and a thickness L2 in a portion contacting the insertion member in the cover forming the fitting hole satisfy a relationship of (L1+L2)xe2x89xa6Dxe2x89xa6Dmax. This makes it possible to both infuse and collect liquid as well as hold the insertion member reliably.
In the liquid communication adapter according to the present invention, it is preferable that a material for the valve is selected from the group consisting of a silicone rubber, a natural rubber, a synthetic rubber and a thermoplastic elastomer. By selecting such materials, it becomes easier to keep functions such as air-tightness, insertion characteristics and reclosing characteristics.
Moreover, in the liquid communication adapter according to the present invention, it is preferable that at least two protrusions are provided in a periphery of a side surface of the cover, and the liquid communication adapter has an anchor means for anchoring the insertion member by a cylindrical lock adapter whose bottom is provided with notches engaging with the protrusions, that has the insertion member inserted and restrained therethrough and inserts the insertion member into the insertion hole and rotates the bottom, thereby engaging the notches provided at the bottom with the protrusions of the cover. This makes it possible to use even an insertion member that cannot be inserted directly into the container cap, for example, a luer of a luer lock syringe.